Details for New Drug Application (NDA): 091105
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NDA 091105 describes ELINEST, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ELINEST profile page.
The generic ingredient in ELINEST is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
The generic ingredient in ELINEST is ethinyl estradiol; norgestrel. There are twenty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestrel profile page.
Summary for 091105
| Tradename: | ELINEST |
| Applicant: | Novast Labs Ltd |
| Ingredient: | ethinyl estradiol; norgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091105
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELINEST | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 091105 | ANDA | Northstar Rx LLC | 16714-365 | 16714-365-01 | 1 BLISTER PACK in 1 PACKET (16714-365-01) / 1 KIT in 1 BLISTER PACK |
| ELINEST | ethinyl estradiol; norgestrel | TABLET;ORAL-28 | 091105 | ANDA | Northstar Rx LLC | 16714-365 | 16714-365-02 | 1 BLISTER PACK in 1 CARTON (16714-365-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.03MG;0.3MG | ||||
| Approval Date: | Mar 28, 2012 | TE: | AB | RLD: | No | ||||
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